Black Diamond Networks – CQV Case Study
Synopsis:
A contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of complex API’s and drug product manufacturing received a substantial amount of additional work from an existing client. To fulfill the client’s requirements, the CDMO would need to expand one of their facility’s capabilities which would include adding new filling lines, retrofitting existing lines, building-out a new clean room, new utilities and extension of utilities and other activities to prepare for the increased demands.
Challenges:
The expansion posed a challenge as permitting and construction delays tightened the timeline for completion of the commissioning, qualification and validation activities. The CDMO’s existing team would need the support of a substantial amount of additional highly skilled resources as well as help with developing accelerated timelines and deliverables, project management and the ability to react and adjust to any delays or changes.
Actions:
Black Diamond Networks (BDN) reacted quickly to collaborate with the project stakeholders to understand the goals and timelines, and then presented a comprehensive project plan which outlined the deliverables, time estimates, resources requirement, project management and reporting framework, and identified the risks and roadblocks with corresponding mitigation plans. Once receiving management approval, BDN assembled the project team and quickly began to execute the plan. The team, consisting of the Account Executive, Project Manager and four experienced validation engineers, efficiently worked around the equipment and installation delays, procured equipment, preformed additional testing and effectively negotiated the way through numerous unforeseen events to ensure the successful completion of the project.
Results:
Most importantly, Black Diamond Network’s solution enabled the CDMO to meet their customer’s expectations and deliver the required work on time. BDN’s team also created numerous GMP compliant templates and documentation that could be utilized for future expansions and validation activities. BDN demonstrated the ability to navigate challenges and built a lasting trust with the CDMO empowering them to confidently take on expanded customer requests.
